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Plga microparticles, sustained release formulation thereof and method for manufacturing same

A technology of PLGA and manufacturing method, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, and devices for making drugs into special physical or taking forms, which can solve problems such as no records, and achieve the effect of exerting pharmacological effects

Pending Publication Date: 2021-10-08
M TECHN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In Patent Document 8, there is no description of approximately spherical PLGA microparticles containing physiologically active substances that are much larger than these nanoparticles and have a diameter of 1 μm or more.

Method used

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  • Plga microparticles, sustained release formulation thereof and method for manufacturing same
  • Plga microparticles, sustained release formulation thereof and method for manufacturing same
  • Plga microparticles, sustained release formulation thereof and method for manufacturing same

Examples

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Embodiment 1

[0167]

[0168] Three mixed solvents were prepared by mixing dichloromethane (manufactured by Kanto Chemical Co., Ltd.) and acetone (manufactured by Kanto Chemical Co., Ltd.) at mixing ratios (W / W) of 7:3, 1:1, and 3:7, respectively. . A lactic acid-glycolic acid copolymer (PLGA7520, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) was added to the above three mixed solvents so that the lactic acid-glycolic acid copolymer was 7% by mass, and a high-speed rotary disperser Clearmix Dissolver ( manufactured by M-Technique) was dissolved to obtain three kinds of PLGA solutions. Ion-exchanged water was added to polyvinyl alcohol 3,500, partially saponified type (PVA, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) so as to make it 1.0% by mass, using a high-speed rotary disperser Clearmix (manufactured by M-Technique) This was dissolved to obtain a PVA aqueous solution. Add PVA aqueous solution in advance to the recovery tank of PLGA emulsified pa...

Embodiment 2

[0177]

[0178] Dichloromethane (manufactured by Kanto Chemical Co., Ltd.) was added to lactic acid-glycolic acid copolymer (Resomer RG504, manufactured by Evonic) so that the lactic acid-glycolic acid copolymer was 20% by mass, and a high-speed rotary disperser ClearmixDissolver (manufactured by M -Technique) was dissolved to obtain a PLGA solution. Then, filtration was performed using a 0.2 μm Aervent filter (φ62, manufactured by MERCK). Ion-exchanged water was added to polyvinyl alcohol (PVA, EG-40P, manufactured by Nippon Synthetic Chemical Industry) so that the polyvinyl alcohol was 1.5% by mass, and it was dissolved using a high-speed rotary disperser Clearmix (manufactured by M-Technique), Thus, an aqueous PVA solution was obtained. Then, filtration was performed using a hydrophilic PVDF membrane filter (φ47, manufactured by MERCK Corporation). Add PVA aqueous solution in advance to the recovery tank of PLGA emulsified particles, and stir until the liquid level ...

Embodiment 3

[0183] A PLGA microparticle suspension was prepared under the same conditions as in Example 2, except that a pressure of 0.01 MpaG was applied to the recovery tank and the effluent was collected under positive pressure. The average volume-based particle diameter of the obtained PLGA microparticles was 50.655 μm, and the R.S.F was 0.99.

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Abstract

The present invention provides: roughly spherical poly(lactic-co-glycolic acid) (PLGA) microparticles which have a volume-based average particle diameter of 1-150 [mu]m inclusive, the relative span factor (R.S.F.) of which satisfies requirement (1): 0.1<(R.S.F.)<=1.7 [wherein: R.S.F. means (D90-D10) / D50; D90 represents a particle diameter corresponding to 90 vol% accumulated from the smaller particle side in the cumulative particle size distribution; D50 represents a particle diameter corresponding to 50 vol% accumulated from the smaller particle side in the cumulative particle size distribution; and D10 represents a particle diameter corresponding to 10 vol% accumulated from the smaller particle side in the cumulative particle size distribution] and which contain a physiologically active substance; and a method for efficiently manufacturing the same. According to the present invention, provided are roughly spherical PLGA microparticles which include few coarse or fine particles, show a sharp particle diameter distribution centering on a desired particle diameter, and have a volume-based average particle diameter of 1-150 [mu]m inclusive, without performing a classification step.

Description

technical field [0001] The present invention relates to a lactic acid-glycolic acid copolymer (PLGA) microparticle, its sustained-release preparation and its manufacturing method, especially approximately spherical PLGA microparticles containing physiologically active substances, its sustained-release preparation and its manufacturing method. Background technique [0002] Recently, microspheres or nanospheres have attracted attention as sustained-release preparations of drugs and the like containing physiologically active substances. Microspheres generally refer to preparations with a particle size of about 1 μm to 150 μm, and preparations with a particle size smaller than 1 μm are called nanospheres. For example, these can be achieved by encapsulating physiologically active substances in synthetic polymers or natural polymers for local continuous release of physiologically active substances, or targeting of physiologically active substances to tissues. [0003] For sustain...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61J3/06A61K47/34
CPCA61K9/10A61K9/1647A61K9/1694A61K9/0024A61K47/34C08J3/122C08J2367/04
Inventor 榎村真一荒木加永子
Owner M TECHN